Trial Outcomes & Findings for Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life (NCT NCT00870233)
NCT ID: NCT00870233
Last Updated: 2018-10-15
Results Overview
Recruitment status
COMPLETED
Target enrollment
120 participants
Primary outcome timeframe
once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
Results posted on
2018-10-15
Participant Flow
Participant milestones
| Measure |
GYN Pts Undergoing Surgery
This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
GYN Pts Undergoing Surgery
This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Did not undergo laparotomy
|
3
|
|
Overall Study
Incompatible internet browser
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
Baseline characteristics by cohort
| Measure |
GYN Pts Undergoing Surgery
n=120 Participants
This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.Outcome measures
| Measure |
GYN Pts Undergoing Surgery
n=120 Participants
This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
|
|---|---|
|
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Requested to be removed from study
|
18 Participants
|
|
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Did not undergo lapartomy
|
3 Participants
|
|
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Incompatible internet browser
|
2 Participants
|
|
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Died
|
1 Participants
|
|
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Completed preoperative session in STAR
|
69 Participants
|
|
Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery
Didn't complete preop, completed other surveys
|
27 Participants
|
SECONDARY outcome
Timeframe: once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has endedPopulation: Nurses who participated in the study
Outcome measures
| Measure |
GYN Pts Undergoing Surgery
n=9 Participants
This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
|
|---|---|
|
Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.
Left MSK before close of study
|
3 Participants
|
|
Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.
Did not complete Clinician Exit Survey
|
2 Participants
|
|
Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.
Reported increased workload bc of STAR system
|
4 Participants
|
SECONDARY outcome
Timeframe: two yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: weekly starting 7 days after surgery until the 6-week post-operative periodThe percentage of symptoms generated by patients on protocol
Outcome measures
| Measure |
GYN Pts Undergoing Surgery
n=120 Participants
This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
|
|---|---|
|
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
ECOG Performance Status
|
15 percentage of symptoms
|
|
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
Nausea
|
14 percentage of symptoms
|
|
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
Fatigue
|
12 percentage of symptoms
|
|
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
Trouble with Strenuos Activities
|
17 percentage of symptoms
|
|
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
Constipation
|
11 percentage of symptoms
|
|
Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System
Pain
|
11 percentage of symptoms
|
Adverse Events
GYN Pts Undergoing Surgery
Serious events: 0 serious events
Other events: 85 other events
Deaths: 27 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GYN Pts Undergoing Surgery
n=120 participants at risk
This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
online platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.
|
|---|---|
|
General disorders
ECOG Performance Status
|
14.2%
17/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
Gastrointestinal disorders
Nausea
|
13.3%
16/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
General disorders
Fatigue
|
10.8%
13/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
General disorders
Pain
|
7.5%
9/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.8%
7/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.8%
7/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
General disorders
Fever
|
5.0%
6/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
Gastrointestinal disorders
Constipation
|
7.5%
9/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
|
Gastrointestinal disorders
Diarrhea
|
0.83%
1/120 • Up to 16 weeks (between 6-8 weeks post surgery)
|
Additional Information
Dr. Dennis Chi ME
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5016
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place